CN1830200B - Barbed suture incorporating surgical needle - Google Patents

Abstract

A barbed suture for connecting tissue, and a combination surgical needle and barbed suture. The suture includes an elongated body and a plurality of barbs projecting from the body. Each barb resists movement of the suture in a direction opposite the direction in which the barb faces. The disposition of the barbs on the body may be staggered, twist cut multiple spiral, overlapping, or random. Further, the configuration of the barbs may be a certain spirality angle α, barb cut angle θ, barb cut depth, barb cut length, barb cut distance, corrugated barb underside, arcuate barb base, or varying sizes.

Description

Barbed sutures incorporating surgical needles

technical field

The present invention relates generally to barbed sutures useful for joining body tissue in various procedures, and more particularly, to the configuration and/or configuration of barbs on such barbed sutures. optimization.

Background technique

Various surgical methods using sutures have been used in the past to close or bind together wounds in human or animal tissue such as skin, muscle, tendon, internal organs, nerves, blood vessels, and the like. More specifically, the surgeon may use surgical needles with attached conventional sutures (which may be smooth monofilaments or may be multifilaments) to alternately pierce tissue on opposite sides of the wound so that The wound was closed with sutures. Whether the wound is accidental or surgically produced, loop sutures are a frequently used method, especially for superficial wounds. The surgical needle is then removed and the ends of the suture are knotted, usually by at least three repeated stitches to form the knot.

As is well known, traditional sutures may be nonabsorbable materials such as silk, nylon, polyester, polypropylene, or cotton, or may be bioabsorbable materials such as glycolic acid polymers and copolymers, or lactic acid polymers compounds and copolymers.

Barbed sutures, generally of the same material as traditional sutures, have offered many advantages over closing wounds with traditional sutures since the time they were conceived. Barbed sutures include an elongated body having one or more spaced apart barbs projecting from a surface of the body along the length of the body. The barbs are configured to allow passage of the barbed suture through tissue in one direction, but prevent movement of the barbed suture in the opposite direction. As such, a major advantage of barbed sutures is that they provide non-slip properties. Therefore, barbed sutures do not need to be knotted like traditional sutures. Like traditional sutures, barbed sutures can be inserted into tissue using surgical needles.

For example, U.S. Patent No. 3,123,077 to Alcamo describes an elongated cord for suturing human flesh, wherein the cord has a main body portion and sharp-edged elastic barbs protruding from the main body at an acute angle relative to the main body . Barbed sutures allow passage through tissue in one direction, but prevent movement in the opposite direction.

Sutures with barbs arranged in a bidirectional arrangement, also known as double-arm sutures, are shown in US Patent No. 5,931,855 to Buncke and US Patent No. 6,241,747 to Ruff. More specifically, the suture has barbs facing one end of the suture for about half the suture length and barbs facing the other end of the suture in the opposite direction for the other half of the suture length. This arrangement allows the barbs to move in the same direction when each of the suture ends is inserted into the first and second sides of the wound. Such bi-directional barbed sutures are not only particularly suitable for closing wounds where the edges are easily separated, but also do not require knotted loops to hold the suture ends together.

Of interest are Sulamanidze and Mikhailov from PCT/RU99/00263 published 02.02.2001 (published 08.09.2000 WO 00/51658) with priority RU99103732 (3.03.1999) European Published Patent Application No. 1075843A1, which shows conical barbs arranged continuously along the length of the wire and oriented in a direction opposite to the direction of wire tension, the distance between the barbs being not less than the wire diameter 1.5 times.

Also of interest is US Patent No. 5,342,376 to Ruff. This patent shows an insertion device useful for positioning barbed sutures for wound closure. The insertion device has a tubular body to accommodate the barbed sutures and preferably has a handle to facilitate manipulation of the device by the surgeon. It is recommended that the insertion device be used with barbed sutures, wherein the portion of the suture being inserted includes barbs facing in a direction opposite to the direction of insertion. Such a suture with barbs opposing the direction of insertion is also shown in Ruff '376.

The disclosures of all patents and patent applications mentioned herein are incorporated by reference.

Depending on the depth of barb cut, beveling of the barbs to the monofilament reduces the straight pull tensile strength because the effective suture diameter is reduced. However, according to the USP, the straight pull tensile strength of barbed sutures should be comparable to the minimum knot pull strength of conventional sutures (non-barbed sutures), since conventional Sutures (which must be knotted and must meet a minimum knot pull tensile strength) fail most often at the knot.

To optimize the performance of barbed sutures, it is advantageous to consider varying the barb geometry (barb cut angle, barb cut depth, barb cut length, barb cut distance, etc.) and/or the spatial arrangement of the barbs of. This should enhance not only the tensile strength of the barbed suture, but also the ability of the barbed suture to hold and maintain the edges of the wound together. Unlike conventional sutures, which place tension directly at the knot, barbed sutures can spread the stress along the length of the beveled suture, often evenly along the length. Accordingly, optimizing the configuration and/or configuration of the barbs should further increase the effectiveness of the new barbed sutures in maximizing retention of strength and minimizing gap formation along the wound edge. The latter is particularly advantageous for promoting wound healing.

Furthermore, such new barbed sutures should rapidly approach tissue with suitable tension, relieve tissue deformation, and help minimize scarring due to the self-retaining advantage imparted by the barbs. The new barbed suture is ideal in surgical procedures where minimal scarring is necessary, such as cosmetic surgery, and in space-constrained surgical procedures, such as endoscopic or microsurgery Very useful.

Contents of the invention

Accordingly, the present invention provides a barbed suture for joining human or animal tissue. The barbed suture includes an elongate body having a first end and a second end. The barbed suture also includes a plurality of barbs protruding from the body. Each barb is adapted to resist movement of the barbed suture while in tissue in a direction opposite to the direction the barb is facing. The barbed suture also includes barbs disposed on the body in a configuration selected from the group consisting of a staggered configuration, a twist cut multiple helical configuration, an overlapping configuration, a random configuration, or a combination thereof.

For staggered configurations, twist cut multiple helical configurations, and/or overlapping configurations, the barbs may both face only one of the first and second ends. Alternatively, the barbed suture may have at least a first portion and a second portion, wherein the barbs of the first portion face toward the first end and the barbs of the second portion face toward the second end.

Furthermore, in an alternative embodiment, the present invention provides a barbed suture for joining human or animal tissue, wherein the suture includes an elongate body having a first end and a second end. The suture also includes a plurality of barbs protruding from the body. Each barb is adapted to resist movement of the suture while it is in tissue in a direction opposite to the direction the barb is facing. The suture also includes a barb cut angle θ selected from a range from about 140 degrees to about 175 degrees, a barb cut depth having a cut depth to suture diameter ratio ranging from about 0.05 to about 0.6, a cut length and A barb cut length having a ratio of cut distance to suture diameter ranging from about 0.2 to about 2, a barb cut distance having a cut distance to suture diameter ratio ranging from about 0.1 to about 6, a wavy bottom side, an arcuate bottom, Barbs of variable size or combination configurations.

For twist-cut multiple helix configurations, the barbed suture preferably has a helix angle a ranging from about 5 degrees to about 25 degrees.

For an overlapping configuration, it means that at least two adjacent barbs are provided, where one overlaps the other. During ramping of the barbs, overlap is created by beveling of a barb (ie, overlapping barb) into the top side of another adjacent barb (ie, the overlapped barb), and the like. Thus, a portion of the top side of the overlapped barb becomes a portion of the bottom side of the overlapping barb, and so on. In this way, with the overlapping configuration, the barb cut distance between the overlapping barb and the overlapped barb can be shorter than the barb cut length of the second overlapped barb, whereas typically for barbed sutures, two Barb cut distance between barbs ≥ barb cut length.

In yet another embodiment, the present invention provides a barbed suture for joining human or animal tissue in combination with a surgical needle, wherein the combination includes a barbed suture attached to the surgical needle. The suture includes a plurality of barbs projecting from an elongate body having a first end and a second end. Each barb is adapted to resist movement of the suture while it is in tissue in a direction opposite to the direction the barb is facing. Preferably, the ratio of needle diameter to suture diameter is about 3:1 or less. Suitably, any of the inventive barbed sutures described herein may be attached to a surgical needle.

Description of drawings

Figure 1A is a side view of one embodiment of the present invention showing a barbed suture having barbs arranged at 180 degree staggered intervals;

Figure 1B is a cross-sectional view along line 1B-1B of the barbed suture in Figure 1A;

Figure 2A is a side view of another embodiment of the present invention showing a bi-directional barbed suture having barbs spaced at 180 degree staggered intervals;

Figure 2B is a cross-sectional view along line 2B-2B of the barbed suture in Figure 2A;

Figure 3A is a side view of another embodiment of the present invention showing a barbed suture having barbs arranged at 120 degree staggered intervals;

Figure 3B is a cross-sectional view along line 3B-3B of the barbed suture in Figure 3A;

Figure 4A is a side view of another embodiment of the present invention showing a bi-directional barbed suture having barbs spaced at 120 degree staggered intervals;

Figure 4B is a cross-sectional view along line 4B-4B of the barbed suture in Figure 4A;

Figure 5A is a side view of another embodiment of the present invention showing a barbed suture having barbs arranged in a twist cut multiple helical configuration;

Figure 5B is a cross-sectional view along line 5B-5B of the barbed suture in Figure 5A;

Figure 6A is a side view of another embodiment of the present invention showing a bi-directional barbed suture having barbs arranged in a twist cut multiple helical configuration;

Figure 6B is a cross-sectional view along line 6B-6B of the barbed suture in Figure 6A;

Figure 7A is a cross-sectional side view of a barbed suture, which is bidirectional, with barbs arranged in a twist-cut multiple helical configuration like the barbed suture in Figure 6A, but shown in enlarged section ;

Figure 7B is a cross-sectional side view as in Figure 7A, but rotated and clamped to align the barbs to measure the cut distance between the barbs;

Figure 8 is a side view of another embodiment of the present invention showing a barbed suture with randomly arranged barbs;

9 is a cross-sectional side view of another embodiment of the present invention showing a barbed suture having barbs with a wavy or serrated bottom side;

Figure 10A is a cross-sectional perspective view of another embodiment of the present invention showing a barbed suture having barbs with arcuate bases;

Figure 10B is a cross-sectional top plan view of the barbed suture in Figure 10A;

Figure 10C is a cross-sectional view along line 10C-10C in Figure 10B;

Figure 10D is a cross-sectional view along line 10D-10D in Figure 10B;

Figure 11 is a cross-sectional side view of another embodiment of the present invention showing a barbed suture having barbs of various sizes;

Figure 12A is a cross-sectional side view of another embodiment of the present invention showing a barbed suture having barbs in an overlapping configuration;

Figure 12B is a perspective view of a portion of the overlapping barbs of the suture of Figure 12A;

Figure 12C is a plan view of a portion of the barb of Figure 12B;

Figure 12D is a side view along line 12D-12D of Figure 12C; and

13A, 13B, 13C, and 13D illustrate various surgical needles, wherein a barbed suture is attached to each surgical needle.

Detailed ways

As used herein, the term "wound" means a surgical incision, cut, breach, severed tissue, or accidental wound in human or animal skin, or other human or animal bodily tissue, or which may require suturing, fixation, Or other conditions using another tissue-connecting device.

Also as used herein, the term "tissue" includes, but is not limited to, tissue such as skin, fat, fascia, bone, muscle, organ, nerve or blood vessel, or fibrous tissue such as tendon or ligament.

In addition, the term "polymer" as used herein generally includes, but is not limited to, homopolymers, copolymers (such as block, graft, random and alternating copolymers), terpolymers, etc., and mixtures thereof and variants. Furthermore, the term "polymer" shall include all possible structures of the material. These structures include, but are not limited to, identical, syndiotactic and random symmetries.

Although the suture below is described in a preferred embodiment with a circular cross-section, the suture can also have a non-circular cross-sectional shape, which can increase surface area, as well as facilitate barb formation. Other cross-sectional shapes may include, but are not limited to, ellipses, triangles, squares, parallelepipeds, trapezoids, rhomboids, pentagons, hexagons, crosses, and the like. Typically, the barbs are cut into a filament of a polymer which is formed by extrusion using a die having a circular cross-section, such that the cross-section of the filament is circular as it would be induced during such extrusion. However, extrusion dies can be customized to have any desired cross-sectional shape.

Accordingly, the term "diameter" as used herein is intended to refer to the transverse length of a cross-section, whether circular or some other shape.

Suitable diameters for the inventive sutures described below may range from about 0.001 mm to about 1 mm, and of course, diameters may range from about 0.01 mm to about 0.9 mm, or from about 0.015 mm to about 0.8 mm. Typical diameters range from about 0.01 mm to about 0.5 mm. The length of the suture can vary depending on several factors, such as the length and/or depth of the wound to be closed, the type of tissue to be joined, the location of the wound, and the like. Typical suture lengths range from about 1 cm to about 30 cm, more specifically, from about 2 cm to about 22 cm.

The terms "staggered" and "staggered" as used herein with respect to the configuration of the barbs on the suture are intended to mean that the suture has at least two sets of barbs that are offset relative to each other, wherein the first set is on the suture. Aligned longitudinally, the second set is aligned longitudinally on the suture, but the plane perpendicular to the suture and cut transversely through the suture and intersecting the bottom of the barbs of the first set is not aligned with the bottom of the barbs of the second set intersect.

The barbs protrude from the outer surface of the suture body on which the barbs are disposed. Depending on the end for which the barbed suture is intended to be used, different sized barbs may be employed. Generally, larger barbs are better suited for attaching certain kinds of tissue, such as adipose tissue or soft tissue. On the other hand, smaller barbs are better suited for joining other types of tissue, such as collagen-dense tissue.

As noted above, barbed sutures can be made from the same materials used to make conventional loop sutures. Any particular choice of material for a barbed suture depends on strength and flexibility requirements.

More specifically, barbed sutures can be made from bioabsorbable materials that allow the suture to degrade and thus be absorbed into tissue over time as the wound heals. Typically, bioabsorbable materials are polymers, and depending on the particular polymer chosen, degradation times in the wound range from about 1 month to over 24 months. The use of bioabsorbable materials eliminates the need to remove sutures from the patient.

Johnson&Johnson注册的商标，用于缝合物和缝合物针)。由这样的生物可吸收的材料制成的有倒钩的缝合物在宽范围的应用中是有用的。Various bioabsorbable polymers include, but are not limited to, polydioxanone, polylactide, polyglycolide, polycaprolactone, and copolymers thereof. A commercially available example is polydioxanone (sold as PDS II, a trade name used by Ethicon for marketing surgical sutures), about 67% glycolide and about 33% cyclopropane carbonate. Copolymers (sold as registered trademark of American Cyanamid for use in surgical sutures), and copolymers of about 75% glycolide and about 25% caprolactone (sold as

Johnson & Johnson registered trademark for sutures and suture needles). Barbed sutures made from such bioabsorbable materials are useful in a wide variety of applications.

)、聚醚-酯(诸如聚丁酯，其为对苯二甲酸二甲酯、聚乙二醇四亚甲基醚和1，4-丁二醇的缩聚合，且其由Tyco拥有的公司Davis&Geck和U.S.Surgical在市场上买卖，名字为其为American Cyanamid注册的商标，用于手术缝合物)或者聚氨酯。替代地，不可吸收的材料可以是金属(例如，钢)、金属合金、天然纤维(例如，丝绸、棉线等等)等。Additionally, the barbed suture can be formed from a non-absorbable material, which can be a polymer. Such polymers include, but are not limited to, polypropylene, polyamide (also known as nylon), polyester (such as polyethylene terephthalate, abbreviated here as PET), polytetrafluoroethylene (such as expandable Polytetrafluoroethylene, here abbreviated as ePTFE, and sold by Gore as GOR-

), polyether-esters (such as polybutylene, which is a polycondensation of dimethyl terephthalate, polyethylene glycol tetramethylene ether, and 1,4-butanediol, and which is owned by Tyco Davis & Geck and US Surgical are traded on the market under the name It is a registered trademark of American Cyanamid for use in surgical sutures) or polyurethane. Alternatively, the nonabsorbable material may be metal (eg, steel), metal alloys, natural fibers (eg, silk, cotton, etc.), and the like.

Most of the barbed sutures discussed below are described as having their ends pointed and made of a sufficiently rigid material to allow penetration of tissue. It is contemplated that the end of the barbed suture could include a surgical needle. In this embodiment, the barbed suture is adapted to be attached to the surgical needle by, for example, swaging, groove wrapping, heat shrinking, or eyelet threading, for insertion into tissue.

Attachment by swaging is well described and is usually achieved by inserting the end of the suture into a surgical needle hole disposed longitudinally at one end of the surgical needle (typically, the hole is drilled longitudinally into the needle In one end of the needle), the resulting product is then crimped around the needle hole so that the suture is secured to the surgical needle for insertion into the tissue. Additionally, some surgical needles having a longitudinal hole at one end are heat-shrinkable tubes that heat shrink after insertion of the suture to attach the suture to the surgical needle. Additionally, some surgical needles have a groove or groove at one end into which suture sits and is then wrapped to secure the suture to the needle. Surgical needles with conventional eyelet-type holes disposed laterally in one end of the needle can also be used, but are not preferred for barbed sutures. For the present invention, portions of the discussion below concern surgical needles forged with barbed sutures, but it is contemplated that any other suitable needle attachment means could be used.

The attachment of sutures and surgical needles is described in US Patent No. 3981307 to Borysko, US Patent No. 5084063 to Korthoff, US Patent No. 5102418 to Granger et al., US Patent No. 5123911 to Granger et al., US Patent No. 5123911 to Demarest et al. 5,500,991, US Patent No. 5,722,991 to Colligan, US Patent No. 6,012,216 to Esteves et al., and US Patent No. 6,163,948 to Esteves et al. Methods for making surgical needles are described in US Patent No. 5,533,982 to Rizk et al. Also, note that the surgical needle can be coated, which allows the inventive combination surgical needle/barbed suture needle to be inserted into tissue with less force than if the surgical needle were not coated. The coating may be a polymer, eg a silicone coating. For example, US Patent No. 5,258,013 to Granger et al. describes an improved siliconized surgical needle that requires substantially less force than standard siliconized surgical needles to achieve tissue penetration.

The barbs are disposed on the body of the suture in various arrangements. The barbs may be formed using any suitable method, including injection molding, stamping, cutting, lasering, and the like. With respect to cutting, typically, a polymeric thread or filament is purchased, and then the barbs are cut into the filament body.

Cutting can be manual, but this is labor intensive and not cost effective.

A well-suited cutter is described in Genova et al., US Patent Application Serial No. 09/943733, filed August 31, 2001, assigned to Quill Medical, the disclosure of which is incorporated by reference. Such cutters have multiple blades for beveling the barbs onto the suture filament. A typical cutting machine for making barbed sutures utilizes a cutting table, a vise, one or more blade assemblies, and sometimes a template or guide for the blades. The suture filament is placed on the bed and held in a vise such that the transverse direction of the blade is disposed generally transverse to the suture filament for cutting a plurality of axially spaced barbs disposed on the exterior of the suture filament.

Referring now to the drawings, in which like reference numerals indicate corresponding or similar elements throughout the several views, shown in FIG. 1A is a side view of a barbed suture according to the present invention, generally designated 1 express.

The suture 1 comprises an elongate body 2, which is generally circular in cross-section, and which terminates in an end 4. As shown in FIG. The end 4 is shown in one embodiment as being pointed for piercing tissue, but it is contemplated that the end 4 could comprise a surgical needle (not shown) for insertion into tissue. (The other end is not shown.) Additionally, suture 1 includes a plurality of closely spaced barbs 7, 9 arranged in a staggered bi-directional configuration. More specifically, the axially spaced barbs 7 are disposed radially about 180 degrees from the axially spaced barbs 9 and are staggered relative to the axially spaced barbs 9 such that the barbs 7, 9 face the pointed end 4. The first set of barbs 7 defines a plane that is substantially coplanar with the plane defined by the second set of barbs 9 , thus, due to the radial 180 degree alignment, the barbs 7 , 9 define substantially the same one plane.

FIG. 1B , which is a cross-sectional view along line 1B-1B of suture 1 in FIG. 1A , more clearly shows angle X, ie barb 7 is aligned radially 180 degrees with respect to barb 9 . As can also be seen from FIG. 1B , the stippling shows that the first of the barbs 7 is closer to the pointed end 4 (not shown in FIG. 1B ), and therefore appears larger than the more distant ones due to the staggering. A first barb 9 of the barbs 9 . A transverse plane perpendicular to the suture body 2 and intersecting the base of one of the barbs 7 does not intersect the base of any of the barbs 9 .

The suture 1 can be produced by a cutter that produces two sets of barbs 7, 9 at staggered positions along the suture 1, usually one set at a time, such as described in Serial No. 09/943733 to Genova et al. cutting device.

The first set of barbs 7 is engaged by placing and holding the suture filament in the vise, and then a blade set of predetermined length is engaged at an angle selected to produce the barbs 7 pointing in one direction towards the pointed end 4. produced from suture filaments. After offsetting the blade longitudinally (to create the stagger) approximately half the longitudinal distance between the two barbs 7, and also rotating the suture filament approximately 180 degrees on the vise, a second set of barbs 9 is similarly produced, which Equipped to accommodate the first set of barbs already cut 7.

Shown in Figure 2A is suture 10, which is another embodiment of the present invention and is similar to suture 1 except that suture 10 is bi-directional. Suture 10 includes an elongated body 12 that is generally circular in cross-section. The elongated body 12 terminates in first and second pointed ends 14, 16 for piercing tissue. Also, it is contemplated that one or both ends 14, 16 may include surgical needles (not shown) for insertion into tissue. Additionally, suture 10 includes a plurality of closely spaced barbs 17, 18, 19, 20 arranged in a staggered bi-directional configuration.

More specifically, the plurality of axially spaced barbs 17 are disposed radially about 180 degrees from the plurality of axially spaced barbs 19 and are staggered relative to the plurality of axially spaced barbs 19 such that the barbs 17 , 19 face the pointed end 14 for a portion (approximately half the length) of the suture 10 . Similarly, the plurality of axially spaced barbs 18 are disposed radially about 180 degrees from the plurality of axially spaced barbs 20 and are staggered relative to the plurality of axially spaced barbs 20 such that the barbs 18, 20 faces the pointed end 16 for the other portion of the suture 10 (approximately the other half of the length). The first set of barbs 17 , 18 define a plane that is substantially coplanar with the plane defined by the second set of barbs 19 , 20 . Thus, due to the radial 180 degree alignment of the first set of barbs 17 , 18 relative to the second set of barbs 19 , 20 , all barbs 17 , 18 , 19 , 20 define substantially the same one plane.

Figure 2B is a cross-sectional view along line 2B-2B of suture 10 in Figure 2A, more clearly showing angle X, ie, the radial 180 degree alignment. Due to the staggering, the first of the barbs 17 is closer to the pointed end 14 (not shown in FIG. Stippled representation. A transverse plane perpendicular to suture body 12 that intersects the base of one of barbs 17 does not intersect the base of any of barbs 19 . Likewise, a transverse plane that is perpendicular to suture body 12 and that intersects the base of one of plurality of barbs 18 does not intersect the base of any of barbs 20 .

Suture 10 may be made by the same cutting machine as Suture 1 was made, such as the cutting device described in Ser. No. 09/943733 to Genova et al. above, except for the following changes in blade orientation.

For the first set of bi-directional barbs 17, 18, after placing and holding the suture filament in the vise, the blade engages in approximately half the length of the suture filament with a first cutting action to produce the end facing toward the point 14 barbs 17 in one direction. Next, the blades are rotated 180 degrees so that they are now set in the opposite direction, and on the uncut half length. The blade is then allowed to engage into the other half of the length of the suture filament by a second cutting action to create the barbs 18 facing in the opposite direction towards the pointed end 16 .

Next, the blades are offset longitudinally (to create a stagger) approximately half the longitudinal distance between the two barbs 17, and the suture filament is also rotated approximately 180 degrees on the vise, which is equipped to accommodate the first set already cut Two-way barbs 17,18. Then, for the second set of bi-directional barbs 19 , 20 , the blade is engaged by a first cutting action into about half the length of the suture filament to create the barbs 20 facing in one direction toward the pointed end 16 . After the first cutting action, rotate the blades 180 degrees longitudinally so that they are now set in the opposite direction, and on the uncut half length. The blade is then allowed to engage into the other half of the length of the suture filament by a second cutting action to create the barbs 19 facing in the opposite direction towards the pointed end 14 .

In an alternate embodiment (not shown) for the bi-directional suture 10, portions of the suture 10 having barbs 17, 19 may have them facing towards the pointed end 16 while the suture 10 has barbs 18, 20 The portions can be such that they face towards the pointed end 14. With this variation, the barbed suture will be inserted into the tissue by an insertion device such as that shown in the aforementioned US Patent No. 5,342,376 to Ruff. Also, note that the barbs can be beveled if desired so that there can be two parts with barbs facing one end and one part with barbs facing the other end, or two parts with barbs facing one end and There are two parts with barbs facing the other end, etc. (not shown), so if a part of the barbs does not face the end of the suture adjacent to those barbs, then the barbed suture will be inserted into the tissue by the insertion device .

One advantage of having barbed sutures with a radial 180 degree arrangement of staggers is that the 180 degree spacing is easy to manufacture on relatively small diameter wires, and the staggering improves anchoring performance. In this way, the staggered 180 degree spacing produces effective anchoring properties in thin and delicate tissues where smaller sutures are required.

Referring now to FIG. 3A , shown is a side view of another embodiment of a suture in accordance with the present invention, and indicated generally at 30 . Suture 30 is similar to Suture 1 shown in FIG. 1A except that the radial spacing of sutures 30 is 120 degrees instead of 180 degrees as shown for Suture 1 .

More specifically, suture 30 includes an elongated body 32, which is generally circular in cross-section, terminating in a pointed end 34 for piercing tissue. It is contemplated that end 34 may include a surgical needle (not shown) so that the suture may be inserted into tissue. (The other end is not shown.) Additionally, suture 30 includes a plurality of closely spaced barbs 35 , 37 , 39 arranged such that all face in the same direction toward pointed end 34 . Thus, the configuration of the barbs 35, 37, 39 is unidirectional.

Likewise, the axially spaced barbs 35 are radially disposed approximately 120 degrees from and staggered relative to the axially spaced barbs 37 which are axially spaced apart from the axially spaced barbs 37. The spaced barbs 39 are arranged radially at approximately 120 degrees and are staggered relative to the axially spaced apart barbs 39 . Accordingly, the axially spaced barbs 39 are also disposed approximately 120 degrees away from and staggered relative to the axially spaced barbs 35 . Due to the radial 120 degree alignment, the first set of barbs 35 define a substantially identical plane; the second set of barbs 37 define another substantially identical one plane; and the third set of barbs 39 define yet another substantially identical one. flat. Thus, suture 30 has barbs 35, 37, 39 arranged in a staggered unidirectional 120 degree configuration.

3B is a cross-sectional view along line 3B-3B of suture 30 in FIG. 3A, and shows a more specific angle Y, that is, barb 35 relative to barb 37, barb 37 relative to barb 39, and the radial 120-degree arrangement of the barb 39 relative to the barb 35.

As shown by the stippling, the first of the barbs 35 appears to be larger than the first of the more distant barbs 37 due to the staggered proximity to the pointed end 34 (not shown in FIG. 3B ). hook37. Likewise, a first one of the barbs 37 , 37 , appears to be larger than a first one of the barbs 39 that is even more distant due to the staggered proximity to the pointed end 34 (not shown in FIG. 3B ). A transverse plane perpendicular to suture body 32 and intersecting the base of one of barbs 35 does not intersect the base of any of barbs 37 . Likewise, a transverse plane perpendicular to suture body 32 that intersects the base of one of barbs 37 does not intersect the base of any of barbs 39 . Similarly, a transverse plane perpendicular to suture body 32 that intersects the base of one of barbs 39 does not intersect the base of any of barbs 35 .

Suture 30 may be fabricated by the same cutting machine used to fabricate suture 1, such as the cutting device described in Serial No. 09/943733 to Genova et al., supra. The cutter is now used to create three sets of barbs 35, 37, 39 at staggered positions along the suture 30, usually one set at a time.

The first set of barbs 35 is passed by placing and holding the suture filament in the vise, and then, after being adjusted to a predetermined length, the blade is selected to produce the barbs 35 so that all of the barbs face toward the pointed end 34 Angles of the same direction are bonded into the suture filaments to create.

Next, the blades are offset longitudinally (to create a stagger) approximately half the longitudinal distance between two barbs 35 . The wire is also rotated approximately 120 degrees on the vise equipped to accommodate the first set of barbs 35 that have been cut, and then the second set of barbs 37 is produced in a similar manner.

Likewise, the blades are again offset longitudinally (to create a stagger) approximately half the longitudinal distance between the two barbs 35, and the suture thread is also rotated approximately 120 degrees on the vise, which is equipped to accommodate the first set of barbs already cut. Hook 35 and second set of barbs 37 already cut. After longitudinal movement and rotation, the third set of barbs 39 is produced in a similar manner.

Preferably, each successive barb is beveled at a location approximately 120 degrees around suture body 32 from the preceding barb and does not overlap any other barb.

Referring now to FIG. 4A, shown is suture 40, which is another embodiment of the present invention. Suture 40 is similar to suture 30, except that suture 40 is bi-directional. Suture 40 includes an elongate body 42, which is generally circular in cross-section, and which terminates in first and second pointed ends 44, 46 for piercing tissue. Also, it is contemplated that one or both ends 44, 46 may include surgical needles (not shown) for insertion into tissue. Suture 40 also includes a plurality of closely spaced barbs 47, 48, 49, 50, 51, 52 arranged in a staggered bi-directional configuration.

For approximately half the length of suture 40, axially spaced barbs 47 are disposed approximately 120 degrees circumferentially from axially spaced barbs 49 and are staggered relative to axially spaced barbs 49, axially spaced apart The barbs 49 are disposed radially about 120 degrees away from the axially spaced barbs 51 and are staggered with respect to the axially spaced barbs 51 . Accordingly, the axially spaced barbs 51 are also disposed approximately 120 degrees away from and staggered relative to the axially spaced barbs 47 . As such, a portion of suture 40 has all barbs 47 , 49 , 51 facing the same direction toward pointed end 44 .

For the other half of the length of the suture 40, the axially spaced barbs 48 are disposed radially at approximately 120 degrees from the axially spaced barbs 50 and are staggered with respect to the axially spaced barbs 50, which are axially spaced apart. The open barbs 50 are disposed radially about 120 degrees from and staggered relative to the axially spaced barbs 52 . Accordingly, the axially spaced barbs 52 are also disposed approximately 120 degrees away from and staggered relative to the axially spaced barbs 48 . Thus, another portion of suture 40 has all barbs 48 , 50 , 52 facing the same direction toward pointed end 46 .

Due to the radial 120 degree alignment, the first set of barbs 47, 48 define substantially the same plane; the second set of barbs 49, 50 define another substantially identical plane; and the third set of barbs 51, 52 define Roughly there is another same plane.

Fig. 4B is a cross-sectional view along line 4B-4B of suture 40 in Fig. 4A, more clearly showing angle Y, ie, the radial 120 degree alignment, with more features. As indicated by the stippling, due to the staggering, the first of the barbs 47 is closer to the pointed end 44 (not shown in FIG. Barb 49. Also due to the staggering, a first 49 of the barbs 49 is closer to the pointed end 44 (not shown in FIG. 4B ), and thus, appears larger than a first 51 of the even more distant barbs 51 .

A transverse plane that is perpendicular to suture body 42 and that intersects the base of one of barbs 47 does not intersect the base of any of barbs 49 . Likewise, a transverse plane perpendicular to suture body 42 that intersects the base of one of barbs 49 does not intersect the base of any of barbs 51 . Similarly, a transverse plane perpendicular to suture body 42 that intersects the base of one of barbs 51 does not intersect the base of any of barbs 47 . Likewise, a transverse plane perpendicular to suture body 42 that intersects the base of one of barbs 48 does not intersect the base of any of barbs 50 . Likewise, a transverse plane that is perpendicular to suture body 42 and that intersects the base of one of barbs 50 does not intersect the base of any of barbs 52 . Similarly, a transverse plane perpendicular to suture body 42 that intersects the base of one of barbs 52 does not intersect the base of any of barbs 48 .

Suture 40 may be made by the same cutting machine as Suture 1 was made, such as the cutting device described in Ser. No. 09/943733 to Genova et al. above, except for the following changes in blade orientation.

For the first set of bi-directional barbs 47, 48, after placing and holding the suture filament in the vise, the blade engages in approximately half the length of the suture filament with a first cutting action to create the end facing toward the point 44 barbs 47 in one direction. The blades are then rotated 180 degrees so that they are now set in the opposite direction, and on the uncut half length. The blade is then allowed to engage into the other half of the length of the suture filament with a second cutting action to create barbs 48 facing in the opposite direction toward pointed end 46 .

Next, the blades are offset longitudinally (to create the stagger) approximately half the longitudinal distance between the two barbs 47, and the suture filament is also rotated approximately 120 degrees on the vise, which is equipped to accommodate the first set already cut Two-way barbs 47,48. Then, for the second set of bi-directional barbs 49 , 50 , the blade is engaged by a first cutting action into about half the length of the suture filament to create barbs 50 facing in one direction toward pointed end 46 . After the first cutting action, the blades are rotated 180 degrees so that they are now positioned in the opposite direction, and on the uncut half length of the suture filament. The blade is then engaged by a second cutting action into the other half length of the suture filament to create barbs 49 facing in the opposite direction towards pointed end 44 .

The blades are then again longitudinally offset (to create a stagger) approximately half of the longitudinal distance between the two barbs 47 . Additionally, the suture filament is again rotated approximately 120 degrees on the vise equipped to accommodate the first set of bi-directional barbs 47,48 that have been cut, and the second set of bi-directional barbs 49,50 that have been cut. After longitudinal movement and rotation, the third set of bi-directional barbs 51, 52 are made such that the blade is engaged by the first cutting action in about half the length of the suture filament to produce the end 44 facing toward the point barb 51 in one direction. After the first cutting action, the blades are rotated 180 degrees so that they are now positioned in the opposite direction, and on the uncut half length of the suture filament. Next, the blade is engaged into the other half length of the suture filament with a second cutting action to create barbs 52 facing in the opposite direction toward pointed end 46 .

Preferably, each successive barb is beveled at a location approximately 120 degrees around suture body 42 from the preceding barb and does not overlap any other barb.

In an alternate embodiment (not shown) for bidirectional suture 40, portions of suture 40 having barbs 47, 49, 51 may have them facing toward pointed end 46 while suture 40 has barbs 48 , 50, 52 so that they face towards the pointed end 44. With this variation, the barbed suture will be inserted into the tissue by an insertion device such as that shown in the aforementioned US Patent No. 5,342,376 to Ruff. Also, note that the barbs can be beveled if desired so that there can be two parts with barbs facing one end and one part with barbs facing the other end, or two parts with barbs facing one end and There are two parts with barbs facing the other end, etc. (not shown), so if a part of the barbs does not face the end of the suture adjacent to those barbs, then the barbed suture will be inserted into the tissue by the insertion device .

One advantage of having a suture with barbs in a radial 120 degree alignment is that the barbs exert force in three different planes that complement each other, resulting in maximization of the overall retention of the suture. As mentioned above, interleaving enhances anchoring performance.

Referring now to FIG. 5A, shown is another embodiment of a suture in accordance with the present invention, generally indicated at 60, having radial spacing that is a twist cut multiple helix. Suture 60 includes an elongated body 62 that is generally circular in cross-section. The elongate body 62 terminates in a pointed end 64 for piercing tissue. Also, it is contemplated that end 64 may include a surgical needle (not shown) for insertion into tissue. Additionally, suture 60 includes a plurality of closely spaced barbs 67 disposed about body 62 in a twist-cut multiple helical pattern and facing in the same direction toward pointed end 64 .

Figure 5B is a cross-sectional view along line 5B-5B of suture 60 in Figure 5A. Due to the twist-cut multiple helical configuration, each respective barb 67 appears to get smaller the further away each is from the pointed end 64 (not shown in FIG. 5B ), the illusion of size difference being represented by stippling. shown.

Suture 60 may be fabricated by the same cutting machine used to fabricate suture 1, such as the cutting device described in Serial No. 09/943733 to Genova et al., above. By the twist cutting method, the barbs 67 can be created in a multiple helix, preferably while the suture filament remains stationary rather than rotated as the cut is made.

More specifically, a portion of the suture length that is approximately 7 inches (approximately 178 mm) in length is twisted longitudinally, such as 39 twists for a portion of the suture length that is approximately 4.5 inches (approximately 114 mm). In this way, one end is secured and the other end is grasped and rotated 360 degrees, 39 times, so that part of the suture filament is twisted when the suture is then placed and held in the vice.

Twists are best performed 28 to 50 times, and can be performed more or less, such as 19 to 70 times. Suitably, the twist can be from about 2 twists to about 17 twists per inch, or from about 3 twists per inch to about 15 twists, or from about 5 twists per inch to about 13 twists per inch (25.4 twists per inch). mm).

Next, after being adjusted to a predetermined length, the blade is simultaneously engaged into the suture filament. The cutting action cuts to create the barbs 67 such that all face in the same direction towards the pointed end 64 . When the twist-cut multiple helix barbed suture 60 is released from the vise and unwound, the barbs 67 are disposed as a multiple helix on the suture 60 .

Referring now to FIG. 6A, another embodiment of the present invention, shown generally as suture 70, is shown. Suture 70 is in a twist-cut multiple helix configuration, and thus is similar to suture 60, except that suture 70 is bi-directional. Suture 70 includes an elongated body 72 that is generally circular in cross-section and that terminates in first and second pointed ends 74, 76 for piercing tissue. It is contemplated that one or both ends 74, 76 may include surgical needles (not shown) for insertion into tissue.

Suture 70 also includes a plurality of closely spaced barbs 77 , 78 arranged in two respective helical patterns, each a multiple helix around body 72 . Barbs 77, 78 are disposed on middle portion MP, which is about 3 inches (approximately 76 mm) of suture 70, such that each end portion EP of suture 70 is free of barbs. More specifically, the plurality of barbs 77 are arranged in a multiple helical pattern such that for a portion (approximately half) of the middle portion MP along the length of the suture 70 , all of the barbs 77 face toward the pointed end 74 . Similarly, the plurality of barbs 78 are arranged in a multiple helical pattern such that for another portion (the other approximately half) of the middle portion MP along the length of the suture 70, all of the barbs 78 face toward the pointed end 76.

Figure 6B is a cross-sectional view along line 6B-6B of suture 70 in Figure 6A. Due to the multiple helical configuration, each respective barb 77 appears to get smaller the further away each is from the pointed end 74 (not shown in FIG. 6B ), as shown by the stippling.

Suture 70 may be made by the same cutting machine as suture 60 was made, such as the cutting device described in Ser. No. 09/943733 to Genova et al. above, but with the following variation in blade orientation. Using the torsional cutting method, barbs 77 can be produced as multiple helices that are preferably simultaneously produced, and then, after a change in direction for the barbs, barbs 78 can be produced as multiple helices that are preferably simultaneously produced. In this way, the suture filament remains stationary, rather than rotating, during cutting.

More specifically, approximately a 4.5 inch (approximately 114 mm) portion of the suture filament length is twisted, such as 39 times for a suture approximately 7 inches (approximately 178 mm) in length. In this way, one end is secured and the other end is grasped and rotated 360 degrees, 39 times, so when the suture is then placed and held in the vise, the twisted portion of the suture filament has approximately 82 degrees per inch (per 25.4 mm). /3 twists.

Twists are best performed 28 to 50 times, and can be performed more or less, such as 19 to 70 times. Suitably, the twist can be from about 2 twists to about 17 twists per inch, or from about 3 twists per inch to about 15 twists, or from about 5 twists per inch to about 13 twists per inch (25.4 twists per inch). mm).

Next, after being adjusted to the predetermined length, the blade engages in a first cutting motion about half of the approximately 3 inch (approximately 76 mm) length of the medial portion MP of the approximately 4.5 inch (approximately 114 mm) twisted portion of the suture filament , causing the blade to cut to create barbs 77 such that all of the barbs face in one direction toward pointed end 74 . Depending on how many blades are on the cutter, and how many barbs 77 are needed, there can be one cutting motion to cut all of the barbs 77 at the same time, or there can be repeated cutting motions until the desired number of barbs 77 are beveled to the suture filament part of.

The blades are then rotated 180 degrees so that they are now positioned in the opposite direction and over approximately half of the approximately 3 inch (approximately 76 mm) length of the medial portion MP of the approximately 4.5 inch (approximately 114 mm) twisted portion of the suture filament . The blade is then allowed to engage into the other half in a second cutting action such that the blade cuts to create the barbs 78 such that all of the barbs face in the opposite direction towards the pointed end 76 . Depending on how many blades are on the cutter, and how many barbs 78 are desired, there can be one cutting motion to cut all of the barbs 78 at the same time, or there can be repeated cutting motions until the desired number of barbs 78 are beveled to the suture filament part of.

When the twist-cut multiple spiral barbed suture 70 is released from the vise and unwrapped, the first and second cuts cause the barbs 77, 78 to be in two separate positions on two respective portions of the suture 70. Each of the multiple helical patterns, the two respective sections define a medial portion MP approximately 3 inches (approximately 76 mm) long.

More specifically, several twist-cut multiple helical, barbed sutures were made of polydioxanone (which is a synthetic absorbable suture material) having a diameter of about 0.018 inches (about 0.457 mm) Made of spun monofilament. A synthetic absorbable suture with a diameter of about 0.018 inches (about 0.457 mm) is slightly larger than a size 0 synthetic absorbable suture having a diameter ranging from about 0.35 mm to about 0.399 mm according to the United States Pharmacopeia (USP). diameter of.

Each suture contained a total of 78 barbs introduced in two respective multiple helical patterns around the circumference of the suture. Since barbed sutures are bi-directional, the barbs are divided into left groups having 39 barbs disposed on the first portion of the suture, and right groups having 39 barbs disposed on the second portion of the suture groups, each set in the opposite direction from the other set from about the middle of the suture. The special cutter used has 13 blades. Thus, for each set of 39 barbs, there are 3 cutting movements (3 x 13 = 39), for each of the 3 cutting movements the blade is deflected by the guide.

Each suture is approximately 7 inches (approximately 178mm) long. The middle portion MP is approximately 3 inches (approximately 76 mm) long and contains 78 barbs that bevel into the suture filament. Extending over 3 inches (76 mm) of the barbed middle portion MP are two suture unbarbed end portions EP, each approximately 2 inches (approximately 51 mm) long. Depending on the suturing technique, one or both ends of the barbed suture may be sufficiently pointed and rigid to be inserted into tissue, or may include straight or curved surgical needles.

The strength of twist cut 7 inch (178 mm) barbed sutures was tested by two methods. One way is through the Universal Tester's straight pull tensile strength test, and the other way through the dog's in vivo performance test.

For CZ tensile strength measurements, Test Resources Universal Tester, Model 200Q was used for testing. The average reading of 10 replicate measurements taken for each type of suture was recorded for barbed sutures and for comparison non-barbed sutures.

The unbarbed suture used for comparison was polydioxane with various suture diameters of about 0.018 inches (about 0.457 mm), about 0.015 inches (about 0.381 mm), and about 0.0115 inches (about 0.292 mm). Hexanone monofilaments (synthetic absorbable suture material), which are slightly larger than USP sizes 0, 2-0, and 3-0 for synthetic absorbable sutures, respectively. According to USP regulations for synthetic absorbable sutures, size 0 has a diameter ranging from about 0.35 mm to about 0.399 mm; size 2-0 has a diameter ranging from about 0.30 mm to about 0.339 mm; and size 3- O has a diameter ranging from about 0.20 mm to about 0.249 mm.

Each barbed suture is clamped at each end by being held by a cork washer backing in two respective serrated pliers, while each unbarbed suture is clamped by wrapping around two respective capstan roller clamps objects are clamped at each end. Capstan rollers are used to hold sutures without barbs to avoid stress and stretching.

The portion of each suture sample between the two clamped places is approximately 5 inches (approximately 126 mm) long, and in the case of barbed sutures, it contains the entire 3 inches (76 mm) of barbed middle part.

Each sample was pulled longitudinally at a rate of approximately 10 inches (approximately 254 mm) per minute until failure occurred. The peak load is recorded as the straight pull tensile strength.

These results are summarized in Table 6A below, with the rightmost column representing the minimum requirements for the USP knot pull test for conventional (barbless) sutures made of synthetic absorbable materials.

Form 6A

(tensile strength)

With barb or without barb suture size straight pull (lbs) USP Minimum Requirements for Knot Pull (lbs) no barb 0 17.72 8.60 no barb 2-0 11.86 5.91 no barb 3-0 8.82 3.90 with barbs 0 7.03 no application

As can be seen, the beveling of the barbs to the size 0 polydioxanone monofilament reduces the straight pull resistance compared to the conventional size 0 polydioxanone monofilament without barbs. The tensile strength is approximately 60% (7.03 lbs = 40% of 17.72 lbs).

However, barbed sutures for size 0 polydioxanone (which have a smaller diameter than conventional size 0 polydioxanone sutures without barbs due to the beveling of the barbs) The straight pull tensile strength of 7.03 lbs at rupture compares favorably with the minimum USP knot pull requirement of 8.60 lbs for size 0 polydioxanone conventional unbarbed sutures.

Additional straight pull tensile strength tests were performed on additional size 0 polydioxanone barbed sutures, as discussed below in Tables 7K-7Z in connection with Figures 7A and 7B.

For in vivo performance, 3 mongrel dogs, approximately 14 kg each, were used. For each dog, 7 incisions were made at the chest (2), thigh (2), ribs, ventral midline and paramedian, each of the 7 incisions had 1, 2 or 3 closed positions. The length of each incision ranges from about 0.5 inches (about 12.5 mm) to about 4 inches (about 101 mm), and the depth of each incision is from the superficial skin to the peritoneum.

Twenty-four of the sites were closed using barbed sutures (all made from size 0 polydioxanone monofilament). For comparison, the remaining sites were treated with conventional unbarbed sutures of various diameter sizes (1 site with size 2-0 silk woven filament, 6 sites with size 2-0 nylon monofilament, and 7 sites). Each location is closed with a size 3-0 polydioxanone monofilament), which is knotted. All position closures were performed in a randomized scheme.

Dogs were monitored daily and then euthanized on day 14. At mortem, macroscopically evaluate the incision. For a variety of tissues, incision sizes, and locations in dogs, all sites juxtaposed by size 0 polydioxanone barbed sutures remained closed and appeared to be in progress, typically throughout the 14-day observation period. heal. Cracking did not occur.

Sites apposed by conventional unbarbed silk sutures, as well as sites apposed by conventional unbarbed polydioxanone sutures also healed without complications. Cracking did not occur.

Of the 6 topical skin sites closed with size 2-0 nylon monofilament conventional unbarbed sutures, 3 sites showed partial or complete suture loss, apparently due to damage to the dog itself. The knots of traditional sutures can be uncomfortable due to the localized pressure that animals do not understand that they should not be manipulating the sutures. Therefore, barbed sutures should help avoid issues with animal handling and pulling out sutures.

In conclusion, when unbarbed sutures of size 2-0 silk braided filaments, size 2-0 nylon monofilament unbarbed sutures, and size 3-0 polydioxanone monofilaments The in vivo performance of the size 0 polydioxanone barbed suture was effective when compared to the silk unbarbed suture.

In an alternate embodiment (not shown) for a bidirectional twist-cut multiple helical suture 70, the portion of the suture 70 on which the barb 77 is disposed may have the barb 77 facing toward the pointed end 76, while The portion of the suture 70 on which the barb 78 is disposed may have the barb 78 facing toward the pointed end 74 . With this variation, the barbed suture will be inserted into the tissue by an insertion device such as that shown in the aforementioned US Patent No. 5,342,376 to Ruff. Also, if desired, note that the barbs can be beveled so that there can be two parts with barbs facing one end and one part with barbs facing the other end, or two parts with barbs facing one end and There are two parts with barbs facing the other end, etc. (not shown), so if a part of the barbs does not face the end of the suture adjacent to those barbs, then the barbed suture will be inserted into the tissue by the insertion device .

One advantage of barbed sutures with twist-cut multiple helix configurations is that such barbed sutures provide better wound retention than barbed sutures spaced 120 degrees apart. The rationale is that the multiple helical pattern of twist cuts results in sets of barbs supplementing successive and preceding sets of barbs, which tends to provide improved anchoring of the suture while it is in tissue. This feature is particularly useful for tissues such as adipose tissue, which have fewer connecting fibers than other types of tissue and therefore require greater suture retention.

Referring now to FIG. 7A , shown is a cross-sectional side view of barbed suture 80 . Barbed suture 80 has a plurality of closely spaced barbs 81 on an elongated suture body 82 of generally circular cross-section. Each barb 81 has a barb tip 85 . Shown are the suture longitudinal axis A, suture diameter SD, barb length L, barb cut depth D, barb cut angle θ, cut distance P, helix angle α, cut away depression CD, and cut away The tip T of the depressed CD.

FIG. 7B is a cross-sectional side view as shown in FIG. 7A , but rotated and clamped to align the barbs for measuring the cutting distance P between the barbs 81 .

Barbed suture 80 is a twist-cut multiple helix bi-directional barbed suture, like suture 70 in FIG. Object diameter SD, barb length L, barb cut depth D, barb cut angle θ, cut distance P, helix angle α, cut away depression CD, and the configuration of the barb 81 at the tip T of the cut away depression CD for more details.

More specifically, several twist-cut multiple helical barbed sutures were made from synthetic absorbable sutures spun from polydioxanone and having approximately 0.018 inches (approximately 0.457 mm, which is slightly larger than size 0 The diameter of the monofilament is made according to the USP requirement of the material. Each suture contained a total of 78 barbs introduced in two respective multiple helical patterns around the circumference of the suture. Since the barbs are bi-directional, the barbs are divided into a left set of 39 barbs, and a right set of 39 barbs, with each set oriented opposite the other from approximately the middle of the suture. Each suture is approximately 7 inches (approximately 178mm) long. The middle portion is approximately 3 inches (approximately 76 mm) of the suture and contains 78 barbs that bevel into the suture filaments. Extending more than 3 inches (76 mm) toward each suture end are the barbed middle portions of the two unbarbed end portions of the suture filament, each approximately 2 inches (approximately 51 mm) long. Depending on the suturing technique, one or both ends of the barbed suture may be sufficiently pointed and rigid to be inserted into tissue, or may include straight or curved surgical needles.

To characterize the configuration of Barb 81, an Optem Zoom 100 custom microscope with ring illumination and background illumination was used, together with a CCD-type video camera, for measurement selection from each of the left and right groups at a magnification of ×21.5. Set barb 81.

Average values were calculated for 10 replicate measurements (5 from the left set of barbs and 5 from the right set of barbs on the same suture) for each of the cut angles θ and cut depth D ongoing. The barb cut angle θ is measured from the cut surface to the outer surface of the barbed suture 80 . The barb cut depth D is measured along a perpendicular from the outer surface of the barbed suture 80 toward the longitudinal axis A of the barbed suture 80 . These measurements enable the calculation of the cutting length L using the following formula.

L=D/{Sin(180-θ)}

Likewise, the helix angle α was measured microscopically on each barbed suture 80 as follows. When the twisted suture filament is gripped by the vise during cutting of barb 81, the vise leaves a very slight mark, represented as line M, imprinted on the suture filament. Thus, when the twisted suture filament is held in the vise, line M is parallel to the longitudinal axis of the vise. If the vise does not leave a slight mark on the suture filament, then line M can be determined to be parallel to connecting two consecutive cut-away depressions left in the suture body 82 by the bevel formed by the two consecutive barbs 81. CD's two respective terminal T lines. After cutting of the barbs 81, when the barbed suture 80 is released from the vise and loosened so that the suture 80 is free to lie flat, the thread M then wraps around the barbed suture 80 on the suture body 82 A helix is formed, forming a helix angle α.

Specifically for measuring the helix angle α, the Optem Zoom 100 custom microscope was set up with ring illumination at 60 and background illumination at coarse 12 and fine 10. Again, use the imaging analysis system software. Then, the helix angle α is measured between the outer surface of the barbed suture and the thread M. Means were calculated for 10 replicate measurements (5 from the left set of barbs and 5 from the right set of barbs on the same suture).

The barbed suture 80 is then installed in the twisting device by clamping one end of the suture 80 in a fixed position. The other end of the suture 80 is rotated to insert the twist until the barbs 81 are aligned. Next, on the barbed suture 80, the longitudinal cut distance P of two adjacent barbs 81 is left in the suture body 82 by the chamfer formed by the two consecutive barbs 81. Measure microscopically between the two respective terminals T of the cut-out depression CD. Means were calculated for 10 replicate measurements (5 from the left set of barbs and 5 from the right set of barbs on the same suture).

The results are summarized in Tables 7A, 7B, 7C and 7D below.

Form 7A (Barbed Suture Size 0)

Measurement unit Left right Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 156±2 157±1 no application Depth of cut D mm 0.15±0.02 0.16±0.04 0.35 Cutting length L mm 0.36±0.03 0.40±0.10 0.87 Cutting distance P mm 0.90±0.17 0.88±0.15 1.92

Form 7B (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 151 1.642 no application Cutting depth D mm 0.215 0.027 0.47 Cutting length L mm 0.446 0.042 0.97 Cutting distance P mm 0.962 0.073 2.1 Helix angle α Spend 20.833 1.602 no application

Form 7C (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 154 2.870 no application Cutting depth D mm 0.205 0.033 0.45 Cutting length L mm 0.469 0.044 1.03 Cutting distance P mm 0.975 0.103 2.13 Helix angle α Spend 19.333 1.506 no application

Form 7D (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 155 2.390 no application Cutting depth D mm 0.186 0.026 0.41 Cutting length L mm 0.437 0.039 0.96 Cutting distance P mm 0.966 0.071 2.11 Helix angle α Spend 18.833 2.137 no application

Also, some additional bi-directional twist-cut multiple helical barbed sutures with a diameter of approximately 0.018 inches (approximately 0.457 mm, which is slightly larger than the USP requirement for a size 0 synthetic absorbable suture) were performed. Additional measurement of angle α. The mean is 16.87 with a standard deviation of ±0.85.

In addition, like suture 80, but with a diameter of approximately 0.0115 inches (approximately 0.292 mm, which is slightly larger than the USP requirement for a size 3-0 synthetic absorbable suture), 3 additional bi-directional twisted cut multiple helices Measurements of barb cut angle θ, barb length L, barb cut depth D, and cut distance P were performed on the barbed suture of 1 and 2 of the 3 additional barbed sutures The measurement of the helix angle α is performed. In addition, 3 additional bi-directional twisted cut multiple helixes like suture 80, but with a diameter of about 0.015 inches (about 0.381 mm, which is slightly larger than the USP requirement for a size 2-0 synthetic absorbable suture) Measurements of barb cut angle θ, barb length L, barb cut depth D, cut distance P, and helix angle α were performed on the barbed suture. These results are summarized in Tables 7E, 7F, 7G, 7H, 7I and 7J below.

Form 7E (Barbed Sutures Size 3-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.292mm) Cutting angle θ Spend 166 1.651 no application Cutting depth D mm 0.107 0.007 0.37 Cutting length L mm 0.443 0.042 1.52 Cutting distance P mm 0.956 0.079 3.27 Helix angle α Spend no test no application no application

Form 7F (Barbed Suture Size 3-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.292mm) Cutting angle θ Spend 164 2.055 no application Cutting depth D mm 0.106 0.006 0.36 Cutting length L mm 0.395 0.042 1.35 Cutting distance P mm 0.959 0.074 3.28 Helix angle α Spend 7.329 0.547 no application

Form 7G (Barbed Suture Size 3-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.292mm) Cutting angle θ Spend 165 1.031 no application Cutting depth D mm 0.104 0.009 0.36 Cutting length L mm 0.390 0.035 1.34 Cutting distance P mm 0.975 0.103 3.34 Helix angle α Spend 7.258 0.636 no application

Form 7H (Barbed Suture Size 2-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.381mm) Cutting angle θ Spend 160.2 1.320 no application Cutting depth D mm 0.152 0.019 0.40 Cutting length L mm 0.449 0.057 1.18 Cutting distance P mm 0.944 0.098 2.48

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.381mm) Helix angle α Spend 9.40 1.606 no application

Form 7I (Barbed Suture Size 2-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.381mm) Cutting angle θ Spend 161.0 1.707 no application Cutting depth D mm 0.158 0.014 0.41 Cutting length L mm 0.489 0.054 1.28 Cutting distance P mm 0.962 0.054 2.52 Helix angle α Spend 7.96 1.075 no application

Form 7J (Barbed Suture Size 2-0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.381mm) Cutting angle θ Spend 161.0 1.506 no application Depth of cut D mm 0.154 0.017 0.40 Cutting length L mm 0.474 0.058 1.24 Cutting distance P mm 0.973 0.068 2.55 Helix angle α Spend 6.53 1.755 no application

Several additional twists are made from polydioxanone spun monofilaments and have a diameter of approximately 0.018 inches (approximately 0.457 mm, which is slightly larger than the USP requirement for a size 0 synthetic absorbable suture) Additional measurements were performed on barbed sutures that cut multiple helices, therefore, similar to the barbed sutures tested above, except that these other barbed sutures were cut with a different cutting machine, i.e., with The machine cuts with a twisted wire moving longitudinally between cutting strokes and is computer controlled to make the various cuts for the beveled one blade of the barb. These other barbed sutures were also tested for straight pull tensile strength and chamois closure strength. (A discussion of how chamois closure strength was performed can be found below in connection with Figures 13A and 13B.) The results for these other barbed sutures are summarized in Tables 7K-7Z below.

Form 7K (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.6 0.718 no application Depth of cut D mm 0.221 0.011 0.48 Cutting length L mm 0.479 0.022 1.05 Cutting distance P mm 0.784 0.015 1.71 Helix angle α Spend 12.9 0.453 no application

Form 7L (barbed suture size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.4 0.947 no application Depth of cut D mm 0.216 0.014 0.47 Cutting length L mm 0.465 0.024 1.02 Cutting distance P mm 0.774 0.015 1.69 Helix angle α Spend 13.2 0.349 no application

Form 7M (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.3 0.576 no application Cutting depth D mm 0.227 0.015 0.50 Cutting length L mm 0.489 0.034 1.07 Cutting distance P mm 0.796 0.018 1.74 Helix angle α Spend 13.1 0.193 no application

Form 7N (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.8 0.612 no application Cutting depth D mm 0.207 0.007 0.45 Cutting length L mm 0.453 0.016 0.99 Cutting distance P mm 0.798 0.017 1.75 Helix angle α Spend 13.6 0.560 no application

Form 70 (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.9 0.549 no application Depth of cut D mm 0.188 0.016 0.41 Cutting length L mm 0.413 0.030 0.90 Cutting distance P mm 0.787 0.024 1.72

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Helix angle α Spend 13.8 0.270 no application

Form 7P (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 153.1 0.655 no application Cutting depth D mm 0.204 0.007 0.45 Cutting length L mm 0.451 0.019 0.99 Cutting distance P mm 0.792 0.018 1.73 Helix angle α Spend 13.6 0.410 no application

Form 7Q (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 163.1 0.505 no application Depth of cut D mm 0.245 0.013 0.54 Cutting length L mm 0.842 0.045 1.84 Cutting distance P mm 0.774 0.009 1.69 Helix angle α Spend 10.8 0.449 no application

Form 7R (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 161.1 1.126 no application Cutting depth D mm 0.233 0.017 0.51 Cutting length L mm 0.721 0.035 1.58 Cutting distance P mm 0.773 0.010 1.69 Helix angle α Spend 12.6 0.189 no application

Form 7S (barbed suture size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 160.9 0.708 no application Cutting depth D mm 0.240 0.014 0.52 Cutting length L mm 0.734 0.037 1.61 Cutting distance P mm 0.774 0.009 1.69 Helix angle α Spend 13.6 0.312 no application

Form 7T (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 154.6 1.434 no application Cutting depth D mm 0.210 0.009 0.46 Cutting length L mm 0.492 0.026 1.08 Cutting distance P mm 0.538 0.011 1.18

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Helix angle α Spend 12.3 0.223 no application

Form 7U (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 152.9 0.809 no application Cutting depth D mm 0.212 0.014 0.46 Cutting length L mm 0.464 0.026 1.01 Cutting distance P mm 0.530 0.015 1.16 Helix angle α Spend 13.7 0.411 no application

Form 7V (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 153.4 0.903 no application Depth of cut D mm 0.221 0.010 0.48 Cutting length L mm 0.495 0.023 1.08 Cutting distance P mm 0.537 0.012 1.17 Helix angle α Spend 13.9 0.605 no application

Form 7W (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 155.2 0.829 no application Cutting depth D mm 0.202 0.008 0.44 Cutting length L mm 0.483 0.017 1.06 Cutting distance P mm 0.789 0.031 1.73 Helix angle α Spend 12.6 0.328 no application

Form 7X (barbed suture size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 155.5 0.799 no application Cutting depth D mm 0.200 0.010 0.44 Cutting length L mm 0.484 0.027 1.06 Cutting distance P mm 0.798 0.017 1.75 Helix angle α Spend 11.8 0.362 no application

Form 7Y (Barbed Suture Size 0)

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Cutting angle θ Spend 155.4 0.560 no application Cutting depth D mm 0.196 0.008 0.43 Cutting length L mm 0.471 0.017 1.03 Cutting distance P mm 0.799 0.019 1.75

Measurement unit Average standard deviation Ratio of D, L or P to suture diameter (0.457mm) Helix angle α Spend 11.8 0.496 no application

Form 7Z

barbed sutures Straight pull strength (lbs) Suede cloth closure strength (cracked pounds) Sample 1 (Form 7K-7M) 7.29 11.23 Sample 2 (Form 7N-7P) 8.73 12.14 Sample 3 (Form 7Q-7S) 8.5 9.22 Sample 4 (Form 7T-7V) 5.92 9.27 Sample 5 (Form 7W-7Y) 7.69 9.97

Although all of the above measurements were performed on bidirectional twist-cut multiple helix barbed sutures, the following measurements of barb length L, barb cut depth D, barb cut angle θ, and/or cut distance P require The range for the various other inventive barbed sutures described here should be the same.

A suitable ratio of cut length L to barbed suture diameter SD ranges from about 0.2 to about 2, more preferably from about 0.4 to about 1.7, even more preferably from about 0.8 to about 1.5. However, a well-suited barbed suture may have a ratio of cut length L to barbed suture diameter SD that decreases from about 1 to about 0.2, so that the highest possible barb height (barb tip 85 at suture The ratio of the height above the object body 82) to the suture diameter SD correspondingly ranges from about 1 down to about 0.2. (The highest possible barb height is the same as barb length L.) Likewise, suitable ratios of cut depth D to barbed suture diameter SD range from about 0.05 to about 0.06, more preferably, from about 0.1 to about 0.55 , and even more preferably, from about 0.2 to about 0.5.

However, the length L can be varied as desired depending on the intended end use, since larger barbs are more suitable for joining certain types of tissue, such as adipose tissue or soft tissue, while smaller barbs are more suitable for joining certain types of tissue, such as Other types of tissue such as fibrous tissue. As discussed in more detail below with respect to FIG. 11, there are also instances where a barb configuration that is a combination of large, medium, and/or small barbs disposed on the same suture is desired, for example, When barbed sutures are used in tissues with structures of different layers.

The cut angle Θ formed between the barbs and the elongated suture body desirably ranges from about 140 degrees to about 175 degrees, and more preferably ranges from about 145 degrees to about 173 degrees. The most preferred cutting angle Θ for all barbs ranges from 150 degrees to about 170 degrees.

For example, for a polydioxanone barbed suture having a diameter of about 0.018 inches (about 0.457 mm), which is slightly larger than the USP requirement for a size 0 synthetic absorbable suture, the preferred barbed The hook length L is 0.45 mm; the preferred barb depth D is 0.2 mm; and the preferred barb cut angle is 153 degrees.

The longitudinal spacing between any two barbs is generally achieved with the goal of creating as many barbs as possible along the suture, and is a factor in the ability of a barbed suture to anchor tissue while maintaining stability . When the barbs are spaced farther apart, the tissue anchoring ability is reduced. However, if the barbs are spaced too closely together, the integrity of the filament may be compromised, which will result in a tendency for the barbs to peel off, and also reduce the suture tensile strength.

Generally, a suitable ratio of the cutting distance P to the diameter SD of the barbed suture ranges from about 0.1 to about 6, more preferably, from about 0.5 to about 4.5, even more preferably, from about 1.0 to about 3.5 . A well-suited barbed suture may have a ratio of cut distance P to diameter SD of the barbed suture falling from about 1.5 to about 0.2 so that cut distance P may be as low as about 0.1, especially for overlapping barbs , which is discussed in more detail below with respect to FIGS. 12A, 12B, 12C, and 12D.

Additionally, the helix angle α formed between thread M and the longitudinal direction of the elongated suture body for twist-cut multiple helical barbed sutures generally ranges from about 5 degrees to about 25 degrees, more preferably, from about 7 degrees. to about 21 degrees. The most preferred angle α for all barbs on a twist-cut multiple helical barbed suture is about 10 degrees to about 18 degrees.

Referring now to FIG. 8, shown is suture 90, which is another embodiment of the present invention. Suture 90 includes an elongated body 92 that is generally circular in cross-section. The elongated body 92 terminates in first and second pointed ends 94, 96 for piercing tissue. It is contemplated that one or both ends 94, 96 may include surgical needles (not shown) for insertion into tissue. Additionally, suture 90 includes a plurality of closely spaced barbs 97 arranged in a random configuration.

Suture 90 may be fabricated by the same cutting machine used to fabricate sutures as described above, such as the cutting device described in Ser. No. 09/943733 to Genova et al., supra. By combining the above methods for performing 180 degree configurations (sutures 1, 10), 120 degree configurations (sutures 30, 40) and/or twist-cut multiple helical configurations (sutures 60, 70, 80), obtained Barbed suture 90 with a very random barb configuration. An advantage of the random configuration is that the many barb angles provide superior anchoring in tissue, which provides superior wound retention properties. In a random configuration, barbed sutures are inserted into tissue by an insertion device such as that shown in the aforementioned US Patent No. 5,342,376 to Ruff.

Referring to Figure 9, shown is a cross-sectional side view of a barbed suture 100, which is another embodiment of the present invention. Suture 100 includes an elongated suture body 102 that is generally circular in cross-section. Likewise, suture body 102 has a plurality of closely spaced barbs 107 disposed thereon. Each barb 107 has a barb configuration such that the barb bottom side 108 is serrated or wavy. One or both suture ends (not shown) are pointed for piercing tissue, and it is contemplated that one or both may include surgical needles (not shown) for insertion into tissue.

Suture 100 may be fabricated by the same cutting machine used to fabricate sutures as described above, such as the cutting device described in Ser. No. 09/943733 to Genova et al., supra. By vibrating or oscillating the cutting blade of the cutting device when the barbs are beveled into the body of the monofilament, a barb 107 with a serrated bottom side 108 is obtained. It is intended that any barbed suture of the invention as described herein may have barbs with a configuration that includes a serrated or undulating bottom side.

Referring now to FIGS. 10A and 10B , depicted in FIG. 10A is a perspective view of a barbed suture 110 and depicted in FIG. 10B is a top view of a barbed suture 110 , which is another embodiment of the present invention. Example. Suture 110 includes an elongated suture body 112 that is generally circular in cross-section. Likewise, suture body 112 has disposed thereon a plurality of closely spaced barbs 115 having barb tips 117 (one barb 115 is shown for clarity). Barb 115 has a configuration with an arcuate base 119 where barb 115 is attached to suture body 112 . One or both suture ends (not shown) are pointed for piercing tissue, and it is contemplated that one or both may include surgical needles (not shown) for insertion into tissue.

10C and 10D are cross-sectional views along line 10C-10C and line 10D-10D of FIG. 10B, respectively. FIGS. 10C and 10D further illustrate that barb 115 narrows from base 119 toward tip 117 .

Suture 110 may be fabricated by the same cutting machine used to fabricate sutures as described above, such as the cutting device described in Ser. No. 09/943733 to Genova et al. above. In order to realize the barb 115 with the arcuate bottom 119 , the cutting device is provided with a cutting blade having a correspondingly arcuate end with respect to the arcuate bottom 119 .

It is intended that any barbed suture of the invention as described herein may have barbs with a configuration that includes an arcuate base. The arcuate base should enhance tissue anchoring compared to the flat linear base. However, there is no need for the base to be round or oval, formed by conical barbs, as this would reduce tissue anchoring.

Shown in FIG. 11 is a cross-sectional side view of a barbed suture, another embodiment of the present invention, and indicated generally at 120 . Suture 120 includes an elongated suture body 122 that is generally circular in cross-section. The elongated body 122 terminates in an end 124 . End 124 is pointed for piercing tissue, and it is contemplated that end 124 may include a surgical needle (not shown) for insertion into tissue. (The other end, not shown, may also be pointed for piercing tissue and may include a surgical needle for insertion into tissue.)

Likewise, suture 120 includes a plurality of proximally spaced barbs 125 , a plurality of proximally spaced barbs 127 , and a plurality of proximally spaced barbs 129 . Barb 125 is relatively small in size and has a relatively short barb length compared to barb 127 which is relatively medium in size and has a relatively medium barb length compared to barb 129 which is relatively large in size , with a relatively long barb length.

Suture 120 may be fabricated by the same cutting machine used to fabricate sutures as described above, such as the cutting device described in Ser. No. 09/943733 to Genova et al., supra. By varying the amount of blade movement during cutting into the suture filament, the barb cutting lengths are made longer or shorter as desired, resulting in each of the three sets of barbs 125, 127, and 129 being sized differently from the others, where , changing sizes designed for use in various surgical applications. The barb size can also vary in the transverse direction so that the barb base can be short, medium or long, however the barb base is usually less than about 1/4 of the diameter of the suture.

For example, relatively larger barbs are suitable for joining fat and soft tissue, while relatively smaller barbs are suitable for joining fibrous tissue. Using a combination of large, medium, and/or small barbs on the same suture helps ensure maximum anchoring properties when barb sizes are customized for each tissue layer. Depending on the intended end use, only two different sized sets of barbs (not shown) may be beveled into suture body 122, or have three sizes other than the set shown for barbs 125, 127 and 129 Additional barb sets (not shown) of four, five, six, or more differently sized sets of four, five, six, or more can be beveled into suture body 122 as desired. Also, while suture 120 is shown with unidirectional barbs, it is intended that barbed sutures having barbs with variable sized configurations in accordance with the present invention may also be bidirectionally barbed. suture, or random barbed sutures, or any of the other inventive barbed sutures described herein.

12A is a perspective view of another embodiment of the present invention showing a barbed suture 130 having an elongate body 132 of generally circular cross-section. One or both suture ends (not shown) are pointed for piercing tissue, and it is contemplated that one or both ends may include surgical needles (not shown) for insertion into tissue.

The suture 130 also includes a plurality of barbs 135 protruding from the body 132 such that at least two longitudinally adjacent first and second barbs 135 are disposed on the body 132, wherein, if the first and second barbs 135, The first barb 135 then overlaps the second barb 135 , which is apparent if the barb 135 lays flat on the body 132 .

12B is a perspective view of a portion of the overlapping barbs 135 of the overlappingly configured barbed suture 130 of FIG. 12A , and FIG. 12C is a top plan view of FIG. 12B . Figure 12D is a cross-sectional view along line 12D-12D of Figure 12C. As can be more clearly seen from FIGS. 12B , 12C and 12D , during ramping of the barb 135 , overlapping the first barb 135 is ramped into the portion of the top side TS of the overlapped second barb 135 , etc. The portion of the top side TS of the second barb 135 that is overlapped becomes the portion of the bottom side US of the first barb 135 that is overlapped.

Thus, with the overlapping configuration, the barb cut distance between the first barb 135 and the second barb 135 can be shorter than the barb cut length of the overlapped second barb 135, while typically for barbed sutures , the barb cut distance between two barbs ≥ barb cut length. Particularly for overlapping barb configurations, well-suited barbed sutures may have ratios of barb cut distance to barb suture diameter ranging from 1.5 down to about 0.2, due to the barb cut distance P Can be as low as about 0.1. (See Figure 7 for the discussion of the comments on barb cut length and barb cut distance.) This overlapping configuration allows for a greater distance between two barbs than when the barb cut distance ≥ barb cut length Many barbs 135 are tightly packed on the top, and generally, the barbs 135 are thin.

Also, while suture 130 is shown with barbs 135 that are unidirectional, it is intended that suture 130 in accordance with the present invention may also be a bidirectional barbed suture as described herein.

13A, 13B, 13C, and 13D illustrate various surgical needles, wherein a barbed suture is attached to each surgical needle. To facilitate insertion into tissue, surgical needles may be coated with a polymer, eg, as described above in US Patent No. 5,258,013 to Granger et al.

Fig. 13A shows surgical needle Nl, which is an elongated needle straight in the longitudinal direction, and which is generally circular in cross-section. Surgical needle N1 has a pointed tip T1 for insertion into tissue and also has a hole H1. Surgical needle N1 is shown attached to barbed suture S1, such as by swaging. Barbed suture S1 is a barbed suture including, but not limited to, any of the barbed sutures described above. Additionally, surgical needle N1 has a diameter D1 in a transverse direction, which appears to be a relatively thin diameter, such as about 0.02 inches (about 0.51 mm). As described above for swaging, after insertion of suture S1 into hole H1 , surgical needle N1 may be crimped about hole H1 by standard procedures to hold suture S1 in place for suturing tissue.

Fig. 13B shows surgical needle N2, which is an elongated needle straight in the longitudinal direction, and which is generally circular in cross-section. Surgical needle N2 has a pointed tip T2 for insertion into tissue and also has a hole H2. Surgical needle N2 is shown attached to barbed suture S2, such as by swaging. Barbed suture S2 is a barbed suture including, but not limited to, any of the barbed sutures described above. Additionally, surgical needle N2 has a diameter D2 in the transverse direction, which appears to be a suitably thin diameter, such as about 0.032 inches (about 0.81 mm), but not as thin as diameter D1 of surgical needle N1. As described above for swaging, after inserting suture S2 into hole H2, surgical needle N2 may be crimped about hole H2 by standard procedures to hold suture S2 in place for suturing tissue.

Fig. 13C shows surgical needle N3, which is an elongated needle curved in the longitudinal direction, and which is generally circular in cross-section. Surgical needle N3 has a pointed tip T3 for insertion into tissue and also has a hole H3. Surgical needle N3 is shown attached to barbed suture S3, such as by swaging. Barbed suture S3 is a barbed suture including, but not limited to, any of the barbed sutures described above. Additionally, surgical needle N3 has a diameter D3 in the transverse direction, which appears to be a relatively thin diameter, such as about 0.02 inches (about 0.51 mm). As described above for swaging, after inserting suture S3 into hole H3, surgical needle N3 may be crimped about hole H3 by standard procedures to hold suture S3 in place for suturing tissue.

Fig. 13D shows surgical needle N4, which is an elongated needle curved in the longitudinal direction, and which is generally circular in cross-section. Surgical needle N4 has a pointed tip T4 for insertion into tissue and also has a hole H4. Surgical needle N4 is shown attached to barbed suture S4, such as by swaging. Barbed suture S4 is a barbed suture including, but not limited to, any of the barbed sutures described above. Additionally, surgical needle N4 has a diameter D4 in the transverse direction, which appears to be a suitably thin diameter, such as about 0.032 inches (about 0.81 mm), but not as thin as diameter D3 of surgical needle N3. As described above for swaging, after inserting suture S4 into hole H4, surgical needle N4 may be crimped about hole H4 by standard procedures to hold suture S4 in place for suturing tissue.

Needle tips T1, T2, T3 and T4 are shown schematically pointed, however, as is well known, surgical needles can have various types of pointed tips such as tapered points, tapered cutouts, ball points, blades , diamond point, thin wire, and lancet point, it is intended to include, but not be limited to, all such needle points. For surgical needles used with barbed sutures, tapered points, tapered cutouts, and diamond points are preferred needle points.

As is well known in the art, the needle diameter of surgical needles used with conventional (i.e., barbless) sutures is considered unimportant, and typically very thick surgical needles are used with thin conventional sutures, The ratio of surgical needle diameter to conventional suture diameter is 4:1 or even higher, such as 4.43:1.

However, with the surgical needle/barbed suture combination (for straight or curved needles) of the present invention, the thinner the surgical needle, the more preferred the surgical needle/barbed suture, as the diameter of the needle As the diameter of the barbed suture is approached, needle diameters of increasingly smaller diameters are required, and needle diameters may even be thinner than the diameter of the barbed suture.

Generally for the present invention, a relatively thin surgical needle attached to a barbed suture for accessing tissue when suturing a wound is more preferred than a relatively thick surgical needle threaded with a barbed suture . The reason is that a relatively thin surgical needle attached to a barbed suture allows for greater engagement of the barbs in the tissue and, therefore, provides a greater closure strength than would be provided to adjacent tissue sutured with a relatively thick surgical needle. , provides better closure strength to already sutured proximal tissue to prevent the opposite sides of the closed wound from pulling apart.

The most important feature of the combination surgical needle attached to a barbed suture is that the surgical needle diameter should be of sufficient width to make a hole or groove at the end, such as by drilling, to allow a barbed suture inserted into holes or grooves. Regardless, as the diameter of the surgical needle increases, the surgical needle remains suitable as long as the ratio of the diameter of the surgical needle to the diameter of the barbed suture is about 3:1 or less.

Thus, for straight or curved needles, the desired ratio of surgical needle diameter to barbed suture diameter is about 3:1 or less, more preferably about 2:1 or less, and most preferably about 2:1 or less. About 1.8:1 or less is preferred. Also, especially if trench needles are used, the ratio of the diameter of the surgical needle to the diameter of the barbed suture can be as small as about 1:1 or less, or even lower, such as about 0.9:1 or less , or about 0.8:1 or less, or as small as about 0.5:1. Those of ordinary skill in the art will appreciate that care should be taken with extremely thin needles so as to improve the likelihood of localized weakening that could disrupt tissue insertion.

The closure strength of the thin surgical needles was tested as follows, both with a ratio of surgical needle diameter to barbed suture diameter suitable for the present invention.

Various pieces of chamois leather (manufactured by U.S. Chamois of Florida) having a thickness of approximately 0.6 inches (approximately 15.2 mm) were cut with wounds having a length of approximately 1.25 inches (approximately 32 mm).

The first sample was produced from a piece of chamois sutured with the edges of the wound stitched together with a surgical needle (product no. 382077A purchased from Sulzle Corporation) forged with a drilled end of a barbed suture. In other words, after the barbed suture is inserted into the needle hole, the needle is crimped around the hole to secure the barbed suture during closure. After suturing the closed wound, the piece of chamois was cut into a rectangular shape approximately 3 inches (approximately 76 mm) long and approximately 1.25 mm (approximately 32 mm) wide, with the sutured wound in the middle of the length and across the width. The needle was a tapered pointed curved surgical needle (3/8 round), approximately 22 mm in length, and a relatively thin diameter of approximately 0.020 inches (approximately 0.51 mm).

Then, using the same suture method, a second sample was produced from another piece of suede manufactured with surgical needles forged with drilled ends of the same type of barbed suture (from Sulzle Co. purchased no.383271A product), that is, after inserting the barbed suture into the needle hole, the needle is crimped around the hole to secure the barbed suture during suturing, suturing the edges of the wound in together. For the second sample, the needles were tapered pointed, curved surgical needles (3/8 round), approximately 22 mm in length, and a suitable fine diameter of approximately 0.032 inches (approximately 0.81 mm), although not as used for the first The sample is as thin as the diameter of the needle.

Each barbed suture used for each sample was a bidirectional, twist-cut multiple helix polydioxanone barbed suture, like suture 70 in FIG. 6A , except that each Each barbed suture has a diameter of about 0.0115 inches (about 0.291 mm, which is slightly larger than the USP requirement for a size 3-0 synthetic absorbable suture), replacing a suture diameter of about 0.018 inches (about 0.457 mm) .

The first and second samples of the stitched chamois cloth were tested for closure strength using a Test Resources Universal Tester, Model 200Q. Each sample is held by two respective serrated jaws. Each sample was then stretched longitudinally at a rate of approximately 10 inches per minute (approximately 254 mm per minute) until complete rupture. The peak load in pounds achieved before complete wound rupture was recorded as the closure strength. The results were that the first sample (which was sutured with a relatively thin needle having a diameter of about 0.020 inches, about 0.51 mm) took 5.88 lbs until wound rupture occurred and the sample was pulled apart into 2 pieces, while the second sample (which Sutured with a needle having a suitably thin diameter of about 0.032 inches, about 0.81 mm, but not as thin as the needle used for the first sample) took only 2.88 lbs until the wound ruptured and the sample was pulled apart into 2 pieces .

The results are summarized in Table 13A below.

Form 13A (Suede cloth closure strength)

sample Needle diameter Barbed Suture Diameter Proportion* cracked pound First 0.020 inches 0.0115 inches 1.74 5.88 second 0.032 inches 0.0115 inches 2.78 2.88

*The ratio of the diameter of the surgical needle to the diameter of the barbed suture

Likewise, different pieces of mouse skin were cut and sutured for more forged surgical needles with barbed sutures tested as follows.

Three freshly killed Sprague-Dawley rats, approximately 600 to 700 grams each, were used. Two full-thickness skin incisions were made on the back of each mouse to create the wound. Each wound was approximately 4 cm long and parallel to the spine.

For each mouse, one of the two wounds was closed with a curved surgical needle at the end of a 3/8 round drill hole, product no. 382273A of Sulzle. The needle had a length of 18 mm and a diameter of approximately 0.022 inches (approximately 0.56 mm). In addition, the needle has a tapered needle tip, wherein the needle tip is ground into a 3-sided cut to approximate a tapered cut needle tip to facilitate piercing murine tissue. The needle is swaged to the barbed suture.

The other two wounds were closed using the same suturing technique, but with a curved surgical needle at the end of a 3/8 round drill hole of Sulzle's no. 832679A product. The needle had a length of 18 mm and a diameter of approximately 0.026 inches (approximately 0.66 mm). In addition, the needle has a diamond-pointed needle tip. The needle is swaged to the barbed suture.

Each barbed suture used for each sample was a bidirectional, twist-cut multiple helix polydioxanone barbed suture, like suture 70 in FIG. 6A , except that each Each barbed suture has a diameter of approximately 0.015 inches (approximately 0.381 mm, which is slightly larger than the USP requirement for a size 2-0 synthetic absorbable suture), replacing a suture of approximately 0.018 inches (approximately 0.457 mm) diameter.

For each sutured wound, a square of approximate dimensions 4 cm x 4 cm such that the sutured wound was parallel to the middle of two opposing tissue edges was retrieved for closure strength testing.

The force to open each wound was determined using a Test Resources Universal Tester, Model 200Q. For each tissue sample, the two edges parallel to each sutured wound were mounted in two respective serrated jaws of the tester.

Each sample was then stretched longitudinally at a rate of approximately 2 inches per minute (approximately 51 mm per minute) until complete rupture occurred. The maximum force encountered before complete wound rupture was recorded as the closure strength.

Results were averaged from the first set of three wounds closed with a needle having a diameter of approximately 0.022 inches (0.56 mm) and swaged to a barbed suture. Likewise, the results were averaged from a second set of three wounds closed with a needle having a diameter of approximately 0.026 inches (0.66 mm) and swaged to a barbed suture.

The results are summarized in Table 13B below.

Form 13B (Mouse Skin Closure Strength)

sample Needle diameter Barbed Suture Diameter Proportion* Average of three wound-ruptured pounds The first group of 3 0.022 inches 0.015 inches 1.47 11.9 The second group of 3 0.026 inches 0.015 inches 1.73 8.1

*The ratio of the diameter of the surgical needle to the diameter of the barbed suture

Thus, the lower the ratio of the diameter of the surgical needle to the diameter of the barbed suture, the better the closure strength when closing a wound closed with the surgical needle attached to the barbed suture. In general, the thinner the surgical needle, the better the closure strength, especially for delicate tissue; however, for tough tissue, such as muscle and bowel, thicker needles are preferred. Therefore, regardless of whether the needle is thick or thin, or in the vicinity of medium, it is important that the ratio of the diameter of the surgical needle to the diameter of the barbed suture should be about 3:1 or less, more preferably about 2:1 or less.

While the invention has been shown and described in detail with respect to only a few exemplary embodiments of the invention, it will be understood by those of ordinary skill in the art that it is not intended to limit the invention to the specific embodiments disclosed. Various modifications, omissions and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages of this invention, particularly in light of the foregoing teachings. For example, the barbed sutures of the present invention may be used alone, or with other closure methods, such as stapling and/or skin bonding, to assist in maintaining tissue in place. Accordingly, it is intended to cover all such modifications, omissions, additions, and equivalents included within the spirit and scope of the invention as defined by the appended claims.

Claims (114)

1. A barbed suture and surgical needle combination for joining human or animal tissue, said combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , and wherein the surgical needle has a ratio of the diameter of the surgical needle to the diameter of the barbed suture at the thickest portion of the needle from about 3:1 to about 1.1:1. 2. The barbed suture and surgical needle combination of claim 1, wherein the attachment of the barbed suture and surgical needle is selected from the group consisting of swaging, groove wrapping, heat shrinking, or eyelet threading group. 3. The barbed suture and surgical needle combination of claim 1, wherein the surgical needle has a polymer coating. 4. The barbed suture and surgical needle combination of claim 3, wherein the polymer coating comprises a silicone material. 5. The combination barbed suture and surgical needle of claim 1, wherein the ratio of the diameter of the surgical needle to the diameter of the barbed suture is from about 2:1 to about 1.1: 1. 6. The barbed suture and surgical needle combination of claim 5, wherein the ratio of the diameter of the surgical needle to the diameter of the barbed suture is about 1.1:1. 7. The barbed suture and surgical needle combination of claim 1, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 8. The barbed suture and surgical needle combination of claim 7, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 9. The barbed suture and surgical needle combination of claim 7, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 10. The combination barbed suture and surgical needle of claim 9, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 11. The combination barbed suture and surgical needle of claim 1 , wherein the configuration of the barbs on the body is selected from the group consisting of staggered configurations, twist cut multiple helical configurations, overlapping configurations, random configurations, and its combined group. 12. The barbed suture and surgical needle combination of claim 11, wherein the barbs are in a staggered configuration, a twist-cut multiple helical configuration, an overlapping configuration, or a combination thereof, and wherein the barbs face only toward Either the first end of the elongated body or the barb faces only towards the second end of the elongated body. 13. The barbed suture and surgical needle combination of claim 11 , wherein the barbs are in a staggered configuration, a twist-cut multiple helical configuration, an overlapping configuration, or a combination thereof, and the barbed suture There is at least a first barbed portion and a second barbed portion, wherein the barbs of the first portion face only toward the first end and the barbs of the second portion face only toward the second end. 14. The barbed suture and surgical needle combination of claim 11, wherein the staggered configuration includes the first set of barbs spaced radially from the second set of barbs by approximately 180 degrees. 15. The barbed suture and surgical needle combination of claim 11 , wherein the staggered configuration includes a first set of barbs radially spaced about 120 degrees from a second set of barbs, and a second set of barbs The set of barbs is radially spaced approximately 120 degrees from the third set of barbs. 16. A barbed suture and surgical needle combination for joining human or animal tissue, said combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , and the barbs are in a twist-cut multiple helical configuration, and when the barbs are beveled into the suture filament to make the barbed suture, the barbed suture consists of from about 2 to about 17 twists per inch The second portion of the suture filament is made, and the surgical needle has a diameter of about 3:1 or less in the ratio of the diameter of the surgical needle to the diameter of the barbed suture at the thickest portion of the needle. 17. A barbed suture and surgical needle combination for joining human or animal tissue, said combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , and the barbs are in a twist-cut multiple helical configuration, and the suture has a helix angle α ranging from about 5 degrees to about 25 degrees, and the surgical needle has the same diameter as the barbed suture at the thickest part of the needle The ratio of the diameters is about 3:1 or smaller diameters. 18. The barbed suture and surgical needle combination of claim 17, wherein the helix angle a ranges from about 7 degrees to about 22 degrees. 19. The barbed suture and surgical needle combination of claim 18, wherein the helix angle a ranges from about 12 degrees to about 18 degrees. 20. A barbed suture and surgical needle combination for joining human or animal tissue, said combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , and the barbs are in an overlapping configuration such that for at least two adjacent barbs, one is an overlapping barb and one is an overlapping barb, the overlapping barb has a bottom side, the overlapping barb has a top side, wherein The portion of the bottom side of the overlapping barbs is derived from the portion of the top side of the overlapping barbs, and the surgical needle has a ratio of the diameter of the surgical needle to the diameter of the barbed suture at the thickest portion of the needle of about 3: 1 or less in diameter. 21. The barbed suture and surgical needle combination of claim 20, wherein each of the overlapping barbs and the overlapped barbs has a barb cut length, and the overlapping barbs and The overlapped barbs have a barb cut distance between them that is shorter than the barb cut length of the overlapped barbs. 22. A barbed suture and surgical needle combination for joining human or animal tissue, said combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barb has a barb cut selected from the group consisting of (i) a barb cut angle θ ranging from about 140 degrees to about 175 degrees, (ii) a barb cut depth to suture diameter ratio ranging from about 0.05 to about 0.6 Depth, (iii) barb cut length to suture diameter ratio ranging from about 0.2 to about 2 barb cut length, (iv) barb cut distance to suture diameter ratio ranging from about 0.1 to about 6 barbs Hook cut distance, (v) wavy barb underside, (vi) arcuate barb base, (vii) at least two sets of barbs each having a different barb size than the other set, and (viii) The configuration of the combined set thereof, and wherein the surgical needle has a diameter at the thickest portion of the needle having a ratio of the diameter of the surgical needle to the diameter of the barbed suture of about 3:1 or less. 23. The barbed suture and surgical needle combination of claim 22, wherein the barb cut angle Θ ranges from about 145 degrees to about 173 degrees. 24. The barbed suture and surgical needle combination of claim 23, wherein the barb cut angle Θ ranges from about 150 degrees to about 170 degrees. 25. The barbed suture and surgical needle combination of claim 22, wherein the ratio of barb cut depth to suture diameter ranges from about 0.1 to about 0.55. 26. The barbed suture and surgical needle combination of claim 25, wherein the ratio of barb cut depth to suture diameter ranges from about 0.2 to about 0.5. 27. The barbed suture and surgical needle combination of claim 22, wherein the ratio of barb cut length to suture diameter ranges from about 0.4 to about 1.7. 28. The barbed suture and surgical needle combination of claim 27, wherein the ratio of barb cut length to suture diameter ranges from about 0.8 to about 1.5. 29. The barbed suture and surgical needle combination of claim 22, wherein the barb cut distance to suture diameter ratio ranges from about 0.5 to about 4.5. 30. The barbed suture and surgical needle combination of claim 29, wherein the barb cut distance to suture diameter ratio ranges from about 1 to about 3.5. 31. The barbed suture and surgical needle combination of claim 16, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 32. The barbed suture and surgical needle combination of claim 31, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 33. The barbed suture and surgical needle combination of claim 31, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 34. The combination barbed suture and surgical needle of claim 33, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 35. The barbed suture and surgical needle combination of claim 16, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 36. The barbed suture and surgical needle combination of claim 16, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 37. The barbed suture and surgical needle combination of claim 17, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 38. The barbed suture and surgical needle combination of claim 37, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 39. The barbed suture and surgical needle combination of claim 37, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 40. The combination barbed suture and surgical needle of claim 39, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 41. The barbed suture and surgical needle combination of claim 17, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 42. The barbed suture and surgical needle combination of claim 17, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 43. The barbed suture and surgical needle combination of claim 20, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 44. The barbed suture and surgical needle combination of claim 43, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 45. The barbed suture and surgical needle combination of claim 43, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 46. The combination barbed suture and surgical needle of claim 45, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 47. The barbed suture and surgical needle combination of claim 20, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 48. The barbed suture and surgical needle combination of claim 20, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 49. The barbed suture and surgical needle combination of claim 22, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 50. The barbed suture and surgical needle combination of claim 49, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 51. The barbed suture and surgical needle combination of claim 49, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 52. The combination barbed suture and surgical needle of claim 51, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 53. The barbed suture and surgical needle combination of claim 22, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 54. The barbed suture and surgical needle combination of claim 22, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 55. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barb has a barb cut angle θ ranging from about 140 degrees to about 175 degrees, and wherein the surgical needle has a ratio of the diameter of the surgical needle to the diameter of the barbed suture of about 3 at the thickest portion of the needle : 1 or smaller diameter. 56. The barbed suture and surgical needle combination of claim 55, wherein the barb cut angle Θ ranges from about 145 degrees to about 173 degrees. 57. The barbed suture and surgical needle combination of claim 56, wherein the barb cut angle Θ ranges from about 150 degrees to about 170 degrees. 58. The barbed suture and surgical needle combination of claim 55, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 59. The barbed suture and surgical needle combination of claim 58, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 60. The barbed suture and surgical needle combination of claim 58, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 61. The combination barbed suture and surgical needle of claim 60, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 62. The barbed suture and surgical needle combination of claim 55, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 63. The barbed suture and surgical needle combination of claim 55, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 64. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture while in tissue in a direction opposite to the direction the barbs are facing , the barbs have a barb cut depth to suture diameter ratio ranging from about 0.05 to about 0.6, and wherein the surgical needle has the diameter of the surgical needle to the barbed suture diameter at the thickest portion of the needle The ratio of diameters is about 3:1 or smaller diameters. 65. The barbed suture and surgical needle combination of claim 64, wherein the ratio of barb cut depth to suture diameter ranges from about 0.1 to about 0.55. 66. The barbed suture and surgical needle combination of claim 65, wherein the ratio of barb cut depth to suture diameter ranges from about 0.2 to about 0.5. 67. The barbed suture and surgical needle combination of claim 64, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 68. The barbed suture and surgical needle combination of claim 67, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 69. The barbed suture and surgical needle combination of claim 67, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 70. The combination barbed suture and surgical needle of claim 69, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 71. The barbed suture and surgical needle combination of claim 64, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 72. The barbed suture and surgical needle combination of claim 64, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 73. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barbs have a barb cut length to suture diameter ratio ranging from about 0.2 to about 2, and wherein the surgical needle has the diameter of the surgical needle to the barbed suture diameter at the thickest portion of the needle The ratio of diameters is about 3:1 or smaller diameters. 74. The barbed suture and surgical needle combination of claim 73, wherein the ratio of barb cut length to suture diameter ranges from about 0.4 to about 1.7. 75. The barbed suture and surgical needle combination of claim 74, wherein the ratio of barb cut length to suture diameter ranges from about 0.8 to about 1.5. 76. The barbed suture and surgical needle combination of claim 73, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 77. The barbed suture and surgical needle combination of claim 76, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 78. The barbed suture and surgical needle combination of claim 76, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 79. The combination barbed suture and surgical needle of claim 78, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 80. The barbed suture and surgical needle combination of claim 73, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 81. The barbed suture and surgical needle combination of claim 73, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 82. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barb has a barb cut distance to a ratio of barb cut distance to suture diameter ranging from about 0.1 to about 6, and wherein the surgical needle has the diameter of the surgical needle to the barbed suture diameter at the thickest part of the needle The ratio of diameters is about 3:1 or smaller diameters. 83. The barbed suture and surgical needle combination of claim 82, wherein the barb cut distance to suture diameter ratio ranges from about 0.5 to about 4.5. 84. The barbed suture and surgical needle combination of claim 83, wherein the ratio of barb cut distance to suture diameter ranges from about 1 to about 3.5. 85. The barbed suture and surgical needle combination of claim 82, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 86. The barbed suture and surgical needle combination of claim 85, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 87. The barbed suture and surgical needle combination of claim 85, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 88. The combination barbed suture and surgical needle of claim 87, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 89. The barbed suture and surgical needle combination of claim 82, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 90. The barbed suture and surgical needle combination of claim 82, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 91. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barb has an undulating barb underside, and wherein the surgical needle has a diameter at a thickest portion of the needle having a ratio of the diameter of the surgical needle to the diameter of the barbed suture of about 3:1 or less. 92. The barbed suture and surgical needle combination of claim 91 , wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 93. The barbed suture and surgical needle combination of claim 92, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 94. The barbed suture and surgical needle combination of claim 92, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 95. The combination barbed suture and surgical needle of claim 94, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 96. The barbed suture and surgical needle combination of claim 91, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 97. The barbed suture and surgical needle combination of claim 91, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 98. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barb has an arcuate barb base, and wherein the surgical needle has a diameter at a thickest portion of the needle having a ratio of the diameter of the surgical needle to the diameter of the barbed suture of about 3:1 or less. 99. The barbed suture and surgical needle combination of claim 98, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 100. The barbed suture and surgical needle combination of claim 99, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 101. The barbed suture and surgical needle combination of claim 99, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 102. The combination barbed suture and surgical needle of claim 101, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 103. The barbed suture and surgical needle combination of claim 98, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 104. The barbed suture and surgical needle combination of claim 98, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 105. A barbed suture and surgical needle combination for joining human or animal tissue, the combination comprising a barbed suture attached to a surgical needle, wherein the suture comprises a plurality of First and second ends and elongated body projecting barbs of a diameter each facing in one direction and adapted to resist movement of the suture in a direction opposite to the direction the barbs are facing while in tissue , the barbs have at least two sets of barbs each having a barb size different from the barb size of the other set, and wherein the surgical needle has the diameter of the surgical needle at the thickest part of the needle and the diameter of the barbed suture The ratio of diameters is about 3:1 or less diameters. 106. The barbed suture and surgical needle combination of claim 105, wherein the suture is made of a material selected from the group consisting of bioabsorbable materials, nonabsorbable materials, and combinations thereof become. 107. The barbed suture and surgical needle combination of claim 106, wherein the bioabsorbable material is selected from the group consisting of polydioxanone, polylactide, polyglycolide , the group of polycaprolactones and combinations thereof. 108. The barbed suture and surgical needle combination of claim 106, wherein the non-absorbable material is selected from the group consisting of polymers, metals, metal alloys, natural fibers, and combinations thereof. 109. The combination barbed suture and surgical needle of claim 108, wherein the polymer is selected from the group consisting of polyamide, polyester, polypropylene, polyurethane, polytetrafluoroethylene, polyether- Group of esters and combinations thereof. 110. The barbed suture and surgical needle combination of claim 105, wherein the barbs face only toward the first end of the elongate body or the barbs face only toward the elongate body. the second end of the main body. 111. The barbed suture and surgical needle combination of claim 105, wherein the barbed suture has at least a first barbed portion and a second barbed portion, wherein , the barbs of the first portion face only toward the first end, and the barbs of the second portion face only toward the second end. 112. The combination barbed suture and surgical needle of claim 1, wherein the ratio of the diameter of the surgical needle to the diameter of the barbed suture is from about 3:1 to about 2.78: 1. 113. The combination barbed suture and surgical needle of claim 1, wherein the ratio of the diameter of the surgical needle to the diameter of the barbed suture is from about 3:1 to about 1.47: 1. 114. The combination barbed suture and surgical needle of claim 1, wherein the ratio of the diameter of the surgical needle to the diameter of the barbed suture is from about 3:1 to about 1.73: 1 or 1.74:1.

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